Apparatus and Method to Access the Bone Marrow for Oncology and Stem Cell Applications
An apparatus for removing portions of bone marrow from a bone is provided. The apparatus includes a housing and a hollow drive shaft operable to engage a gear assembly. The hollow drive shaft includes a first end operable to penetrate the bone and a second end operable to allow retrieval of portions of bone and bone marrow. The apparatus also includes a removable trocar. The removable trocar includes an inner channel operable to convey portions of bone and bone marrow. The gear assembly is able to engage and rotate the hollow drive shaft. A motor operable to drive the hollow drive shaft into the bone marrow by rotation of the hollow drive shaft and a power supply and associated circuitry operable to power the motor are also included.
This application is a divisional of U.S. patent application Ser. No. 11/389,733 entitled “Apparatus and Method to Access the Bone Marrow for Oncology and Stem Cell Applications” filed on Mar. 27, 2006, by Larry J. Miller, which is a divisional of U.S. patent application Ser. No. 10/448,650 entitled “Apparatus and Method to Access the Bone Marrow for Oncology and Stem Cell Applications” filed May 30, 2003, by Larry J. Miller, which claims priority to U.S. Provisional Patent Application Ser. No. 60/384,756, filed May 31, 2002, and entitled “Apparatus and Method to Provide Access to Bone Marrow”. The contents of these applications are incorporated herein in their entirety by this reference.
This application is copending with patent application Ser. No. 11/389,732, filed Mar. 27, 2006, and entitled “Apparatus and Method to Access the Bone Marrow for Oncology and Stem Cell Applications”, which a divisional of U.S. patent application Ser. No. 10/448,650 entitled “Apparatus and Method to Access the Bone Marrow for Oncology and Stem Cell Applications” filed May 30, 2003, by Larry J. Miller, which claims priority to U.S. Provisional Patent Application Ser. No. 60/384756, filed May 31, 2002, and entitled “Apparatus and Method to Provide Access to Bone Marrow”. The contents of these applications are incorporated herein in their entirety by this reference.
This application is also copending to U.S. patent application Ser. No. 10/449,503, filed May 30, 2003, and entitled, “Apparatus and Method To Provide Access To Bone Marrow”; and copending with U.S. patent application Ser. No. 10/449,476, filed May 30, 2003, and entitled “Apparatus and Method to Access Bone Marrow”. The contents of these applications are incorporated herein in their entirety by this reference.
TECHNICAL FIELDThe present invention is related to an apparatus and method for withdrawing specimens from the bone or bone marrow. The apparatus and method can be used to extract stem cells or bone marrow for transplantation or diagnostic purposes.
BACKGROUND OF THE INVENTIONThere are many clinical conditions where it is important to be able to access and retrieve bone marrow. In some cases it may be necessary to treat diseases with a bone marrow or stem cell transplant to restore functioning blood cells in the body after high-dose chemotherapy. Such conditions may include acute leukemias, brain tumors, breast cancer, Hodgkin's disease, multiple myeloma, neuroblastoma, non-Hodgkin's lymphomas, ovarian cancer, sarcoma and testicular cancer. In other cases it is necessary to access the bone marrow to obtain a sample of the marrow for diagnostic testing. These conditions may include cancer of any type and hematologic disease of any origin.
Current techniques for gaining access to bone marrow can be difficult, traumatic and occasionally dangerous, depending on the site selected for harvest, the operator's expertise and the patient's anatomy. In general, the devices available for gaining access to the medullary cavity of the bone, where the bone marrow is located, include a trocar-fitted needle, with handles to facilitate application of pressure and rotation. These types of devices require substantial force to break through the outer cortex of the bone by a fracturing technique. The exertion of high pressure upon the needle causes pain for the patient and often damages the tip of the needle. This is particularly a problem when harvesting from the sternum of a patient because the excess force can cause penetration through the sternum and can damage underlying structures such as the heart and great vessels.
Another disadvantage of current techniques to access the bone marrow is that frequently more than one penetration site into the bone is required to retrieve enough bone marrow to either perform diagnostic tests or for transplantation purposes. To retrieve an adequate sample of bone marrow for either a bone marrow or stem cell transplant, a physician may need to put the needle into several different parts of the pelvis which may require up to six needle puncture sites or more. This multiple-pass requirement can be extremely painful for a patient and may deter people from donating bone marrow. This technique of using multiple passes can also cause fatigue in smaller operators who may lack strength to complete multiple-pass procedures.
Retrieving bone samples for diagnostic purposes is likewise difficult. Occasionally the core sample of bone is not retrieved because it is not extracted successfully with a standard biopsy needle. Thus, multiple attempts may be necessary to obtain a satisfactory bone or bone marrow biopsy.
Current techniques require that biopsy needles be forced by manual pressure into bone. These techniques may have undesirable side effects such as damaging a needle tip or having the needle slide off the proposed bone target and into organs or soft tissues.
SUMMARY OF THE INVENTIONThere is a need for an apparatus and method to access the bone marrow that is minimally traumatic to the patient and that allows a sufficient amount of bone marrow to be removed the first time the bone is penetrated. In accordance with teachings of the present invention, an apparatus and method for the removal of portions of bone marrow from a bone are provided.
In one embodiment the apparatus includes a housing and a hollow drive shaft operable to engage a gear assembly. The hollow drive shaft includes a first end operable to penetrate the bone and a second end operable to allow retrieval of portions of bone and bone marrow. The hollow drive shaft also includes an inner channel operable to convey portions of bone and bone marrow. The apparatus also includes a removable trocar with a first end operable to penetrate the bone and a second end. The removable trocar includes an inner channel operable to convey portions of bone and bone marrow. The gear assembly is able to engage and rotate the hollow drive shaft. A motor operable to engage the gear assembly and drive the hollow drive shaft into the bone marrow by rotation of the hollow drive shaft and a power supply and associated circuitry operable to power the motor are also included.
In another embodiment, an apparatus for removing portions of bone and bone marrow from a bone for diagnostic or therapeutic purposes is provided that includes a housing and a hollow drive shaft operable to engage a gear assembly. The hollow drive shaft includes a first end operable to attach to a penetrator and a second end operable to allow retrieval of portions of bone marrow. The hollow drive shaft also includes an inner channel operable to convey portions of bone marrow to an operator. The detachable penetrator is able to penetrate the bone marrow and collect specimens of bone marrow. Also included is a trocar having a first end operable to penetrate the bone marrow and a second end. The trocar can be removably inserted into the inner channel of the hollow drive shaft. A connector operable to releasably attach the penetrator to a hollow drive shaft is also included. A gear assembly operable to engage and rotate the hollow drive shaft is provided. A motor operable to engage the reduction gear assembly and drive the penetrator into the bone marrow by rotation of the hollow drive shaft and a power supply and associated circuitry operable to power the motor are also provided.
In a further embodiment of the invention a hollow drive shaft assembly operable to remove bone or tissue from a bone marrow is provided. An outer hollow drive shaft and a removable inner trocar operable to penetrate the bone marrow are included. The outer hollow drive shaft is removably coupled to a gear assembly and the outer hollow drive shaft includes an inner channel operable to convey portions of bone and bone marrow.
In a further embodiment of the invention a method for performing a bone marrow biopsy is provided that includes inserting a hollow drive shaft and trocar into the bone marrow by means of a powered apparatus. The trocar may be removed from the hollow drive shaft and suction may be applied to an inner channel of the hollow drive shaft so that portions of bone and bone marrow may be retrieved from the inner channel of the hollow drive shaft.
An alternative method of performing a bone marrow biopsy is provided that includes attaching a penetrator to a hollow drive shaft and inserting an inner trocar into the hollow drive shaft and penetrator. The penetrator is then inserted into the bone marrow by a powered apparatus. The inner trocar is removed from the hollow drive shaft and penetrator, and suction may be applied to the inner channel of the hollow drive shaft to retrieve portions of bone marrow. In a particular embodiment of the invention the site of bone marrow biopsy is controlled by a second end of the trocar comprising a ratcheted gear operable to control the depth of sampling from the bone marrow.
In a further embodiment of the invention, a method of harvesting bone marrow for transplantation is provided that includes inserting a hollow drive shaft and inner trocar into the bone marrow by means of a powered apparatus coupled with the hollow drive shaft. The inner trocar is removed from the hollow drive shaft. A suction is then applied to the inner channel of the hollow drive shaft to retrieve portions of bone marrow. The inner trocar may be replaced into the hollow drive shaft. The steps of removing the inner trocar from the hollow drive shaft and applying suction to the inner channel of the hollow drive shaft to retrieve portions of bone marrow may be repeated until a sufficient quantity of bone marrow has been harvested for bone marrow transplantation.
In a particular embodiment of the invention, the site of harvest within the bone marrow may be changed by a ratcheted gear attached to the second end of the trocar. The gear may be used to change the depth of sampling from the bone marrow.
BRIEF DESCRIPTION OF THE DRAWINGSA more complete and thorough understanding of the present embodiments and advantages thereof may be acquired by referring to the following description taken in conjunction with the accompanying drawings, in which like reference numbers indicate like features, and wherein:
Preferred embodiments of the invention and its advantages are best understood by reference to
Removable trocar 19 may be inserted into inner channel 15 of hollow drive shaft 14. Trocar 19 is hollow and has an inner channel operable to convey bone and bone marrow samples. Trocar 19 may have a handle 8 that can be used to tighten trocar 19 in place or to remove it from inner channel 15 of hollow drive shaft 14. Hollow drive shaft 14 may include luer lock connector 4 at the point where it exits housing 12. A luer lock connector may allow hollow drive shaft to connect to a suction apparatus such as a tubing or syringe or to any other suitable apparatus that would assist in obtaining a bone or bone marrow biopsy specimen. An access port, such as a suction port may also releasably attach to an end of hollow drive shaft where it exits housing 12, for example to a luer lock connector. Such an attachment may be a plug, a port, a suction apparatus, swivel port or other adapter.
In one embodiment, shown in
In another embodiment of the current invention, shown in
FIGS. 2A-D show an end 22 of either a hollow drive shaft or a penetrator that is suitable to penetrate a bone.
The apparatus may or may not include a reduction gear assembly. A reduction gear assembly may include a worm gear assembly shown in more detail in
Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alternations can be made herein without departing from the spirit and scope of the invention as defined by the following claims.
Claims
1. A method for performing a bone marrow biopsy using a hollow drive shaft having an inner channel with a removable trocar disposed in the inner channel comprising:
- inserting a first end of the hollow drive shaft and a first end of the trocar into a bone and associated bone marrow using a powered apparatus;
- removing the trocar from the inner channel of the hollow drive shaft;
- applying suction to the inner channel of the hollow drive shaft; and
- retrieving portions of bone marrow from the inner channel of the hollow drive shaft.
2. The method of claim 1 further comprising:
- connecting a second end of the hollow drive shaft to a suction swivel apparatus;
- attaching one end of a suction tube with the suction swivel apparatus; and
- attaching another end of the suction tube with a receptacle interposed between the suction tube and a source of suction such that a bone marrow specimen may be retrieved into the receptacle.
3. The method of claim 1 further comprising removing the hollow drive shaft from a housing containing the hollow drive shaft after use of the hollow drive shaft.
4. A method of performing a bone marrow biopsy using a hollow drive shaft having an inner channel operable to receive an inner trocar having a split-needle configuration within the inner channel comprising:
- inserting a first end of the hollow drive shaft into a bone and associated bone marrow using a powered apparatus;
- advancing the inner trocar having the split-needle configuration past the first end of the hollow drive shaft to open the inner trocar and insert the inner trocar into the associated bone marrow; and
- closing the inner trocar to retain a bone marrow specimen as the inner trocar is withdrawn from the inner channel.
5. The method of claim 4 further comprising moving the inner trocar between an open position and a closed position.
6. A method of harvesting bone marrow for transplantation using a hollow drive shaft having an inner channel with a removable trocar disposed in the inner channel comprising:
- inserting the hollow drive shaft and the removable trocar into a bone and associated bone marrow using a powered apparatus coupled with the hollow drive shaft;
- removing the removable trocar from the inner channel of the hollow drive shaft;
- applying suction to the inner channel of the hollow drive shaft and retrieving portions of the associated bone marrow;
- replacing the trocar into the hollow drive shaft;
- changing the site of harvest within the bone and associated bone marrow; and
- repeating the steps of removing the trocar from the hollow drive shaft and applying suction to the inner channel of the hollow drive shaft to retrieve portions of the associated bone marrow until a sufficient quantity of bone marrow has been harvested for bone marrow transplantation.
7. The method of claim 6 the step of inserting the hollow drive shaft and the trocar into the bone and associated bone marrow further comprises using a motor engaged to a gear assembly operable to rotate the hollow drive shaft.
8. The method of claim 6 further comprising removing the hollow drive shaft from a housing containing the hollow drive shaft after inserting the hollow drive shaft into the bone and associated bone marrow.
9. A method for performing a bone marrow biopsy using a hollow drive shaft having an inner channel with a trocar disposed in the inner channel comprising:
- inserting the hollow drive shaft and the trocar into a bone and associated bone marrow using a powered apparatus;
- attaching a suction apparatus to a suction port attached to one end of the trocar extending from the hollow drive shaft;
- applying suction to the trocar; and
- retrieving portions of the associated bone marrow from the inner channel of the trocar using the suction apparatus.
10. The method of claim 9 further comprising:
- changing the location in the associated bone marrow where sampling occurs using an operating mechanism attached to the trocar; and
- aligning a sample port in the trocar with a sample port formed in the hollow drive shaft.
11. The method of claim 9 wherein the step of inserting the hollow drive shaft and the trocar into the bone and associated bone marrow further comprises using a suction swivel apparatus that allows attaching a suction tube to the suction port to remain attached while drilling into the bone marrow without twisting the suction tube.
12. The method of claim 9 further comprising selecting portions of the associated bone marrow for removal by limiting longitudinal movement of the trocar.
13. The method of claim 12 wherein the step of selecting portions of the bone marrow for removal further comprises using a ratcheted gear operable to control the depth of sampling from the associated bone marrow.
14. The method of claim 9 further comprising:
- changing the location in the associated bone marrow where sampling occurs using an operating mechanism attached to the trocar; and
- aligning a sample port of the trocar with one of three sample ports formed in the hollow drive shaft.
15. A method for performing a bone marrow biopsy using a hollow drive shaft having an inner channel with a removable removable trocar disposed in the inner channel comprising:
- inserting the hollow drive shaft and the removable trocar into a bone and associated bone marrow using a powered apparatus;
- attaching a suction apparatus to a suction port attached to one end of the removable trocar extending from the hollow drive shaft;
- applying suction to the removable trocar using the suction apparatus; and
- retrieving portions of bone marrow from the inner channel of the removable trocar using the suction apparatus.
16. The method of claim 15 further comprising:
- changing the location in the associated bone marrow where sampling occurs using an operating mechanism attached to the removable trocar; and
- aligning a sample port in the removable trocar with a sample port formed in the hollow drive shaft.
17. The method of claim 15 wherein the step of inserting the hollow drive shaft and the removable trocar into the bone further comprises using a suction swivel apparatus that allows a suction tube attached to the suction port to remain attached while drilling into the associated bone marrow without twisting the suction tube.
18. The method of claim 15 further comprising selecting portions of the bone marrow for removal by limiting longitudinal movement of the removable trocar.
19. The method of claim 18 wherein the step of selecting portions of the associated bone marrow for removal further comprises using a ratcheted gear operable to control the location of sampling from the associated bone marrow.
20. The method of claim 15 further comprising:
- changing the location in the associated bone marrow where sampling occurs using an operating mechanism attached to the trocar; and
- aligning a sample port of the trocar with one of three sample ports formed in the hollow drive shaft.
Type: Application
Filed: Jul 23, 2007
Publication Date: Jan 17, 2008
Inventor: Larry Miller (Spring Branch, TX)
Application Number: 11/781,568
International Classification: A61B 10/02 (20060101);